NCT05814159

A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of Subcutaneous Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 8 Months
• Healthy volunteers: Not accepted

Summary

A study to demonstrate efficacy and safety of anakinra in pediatric and adult Japanese patients with Still's disease (Systemic juvenile idiopathic arthritis \[SJIA\] and Adult-onset Still's disease \[AOSD\]).

Detailed description

The study consists of two phases: • Core phase comprising 2 weeks double blind placebo-controlled treatment, 52 weeks open label treatment and 4 weeks safety follow up (only for patients not entering the extension phase). At the Week 54 visit, patients who consent and are eligible to continue anakinra treatment, will enter the extension phase and continue open label anakinra treatment. • Extension phase comprising up to 26 weeks open label treatment and 4 weeks safety follow up. The primary endpoint will be evaluated at Week 2 visit.

Conditions

• Still's Disease, Juvenile Onset
• Still's Disease, Adult-Onset

Interventions

Type	Name	Description
DRUG	Anakinra	sub cutaneous daily injection
DRUG	Placebo	sub cutaneous daily injection

Timeline

• Start date: 2022-08-24
• Primary completion: 2025-12-10
• Completion: 2026-06-24
• First posted: 2023-04-14
• Last updated: 2025-03-05

Locations

8 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study